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Completed

NCT Number: NCT00721903

Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies

The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.

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Key information

Conditions

Breast Cancers Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

To evaluate the proportions of correct diagnosis of response to breast Cancer therapies for localized breast cancer by ultrasound. To develop a model based on patient characteristics, physical exam, and radiologic studies which will predict the possibility that a patient has had a complete pathological response to chemotherapy neoadjuvant therapy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed breast cancer prior to receiving breast cancer therapy.
  • Diagnosis of breast cancer must be confirmed by fine needle aspiration or core biopsy.

Exclusion criteria

  • Poorly controlled diabetes.
  • Contralateral mastectomy prior to neoadjuvant chemotherapy.
  • Not a surgical candidate.
  • No previous axillary lymph node dissection.

Treatment and study plan

Ultrasound Scan

Procedure

10 female volunteers with normal breast who will be studied to refine imaging techniques and for comparison with patients. To the degree possible, the volunteer group will be age-matched to patients with symptoms, initially 30 to 70 years of age.

Mammography and Ultrasound

Procedure

To determine how well from ultrasound scans, changes in malignant masses can be measured, and to whether the use of a dye visible by ultrasound will be useful in evaluating different therapies for breast cancer.

Primary outcomes

  1. Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.

    Time frame: 2002-2014

    Self explanatory.

Secondary outcomes

  1. Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor.

    Time frame: 2002-2014

    Visually measure separation between two corresponding points in two ultrasound image volumes after registration to verify registration accuracy.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies

Important dates

Study start
2000
Primary completion
2014
Study completion
2014
First posted
Jul 25, 2008
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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